USFDA-Gujarat FDCA Regulatory Forum to be held from 17th to 19th May

This regulatory forum between the USFDA and Gujarat FDCA is designed as a collaborative effort to identify initiatives to further strategic collaboration in regulatory systems.

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FDA

Last Updated on May 19, 2022 by The Health Master

The US Food and Drug Administration (USFDA)-Gujarat Food and Drug Control Administration (FDCA) Regulatory Forum is being held from 17th to 19th May, 2022.

In this meeting, 12 officials from the USFDA, senior officers from Gujarat FDCA and four drug officers nominated by Drugs Controller General of India (DCGI) will participate.

Besides, the USFDA will provide an overview of recent initiatives, including OGPS reorganisation and GMP inspectional trends in India.

The USFDA officials and Gujarat FDCA officials will discuss on Drug Inspection Lifecycle:

  • Site selection,
  • Planning,
  • Execution,
  • Reporting,
  • Evaluation and regulatory action,
  • Case study, and
  • Discuss elements of Observed Inspection SOP for future participation as an observer in the USFDA-led inspection followed by a panel discussion.

This regulatory forum between the USFDA and Gujarat FDCA is designed as a collaborative effort to identify initiatives to further strategic collaboration in regulatory systems.

The forum will also provide an opportunity to share information about the existing practices of the organisations and to explore synergies to advance the public health needs of the regulatory bodies.

Earlier, a meeting was held on 12th March, 2019, at office of the Commissioner, FDCA, Gandhinagar, with Dr Letitia Robinson, Country Director and other officials from the USFDA, along with Dr HG Koshia, Commissioner, FDCA, Gujarat, and other officers from Gujarat FDCA.

As a part of the meeting, it was decided to organise quarterly subsequently meeting between both the regulatory bodies for the exchange/discussion of technical advancement and other regulatory-related information.

In the last meeting, the USFDA officers had met the Gujarat cabinet health minister Rushikeshbhai Patel and additional chief secretary (health), Manoj Agarval. During their discussion, the minister suggested them to visit LM Pharmacy College, Ahmedabad and Government Ayurvedic Hospital, Kolwada on 19th May, 2022.

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